Elumn8 Medical has announced the initial close of its Series C funding and rebrand from Simpson Interventions to Elumn8 Medical.
The investment will be used to advance clinical development of the Acolyte image-guided crossing and re-entry catheter system, which is presently being assessed in a pre-market trial for the treatment of coronary chronic total occlusions (CTOs).
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The rebranding signals the company’s evolution towards advancing image-enabled technologies for coronary interventions. The new name also highlights this as the eighth medical device company founded by Dr John Simpson.
Elumn8 Medical is progressing with its Acolyte pre-market clinical trial, which is assessing the performance and safety of the Acolyte catheter system for patients undergoing CTO percutaneous coronary intervention (CTO-PCI).
The study is recruiting patients at various locations throughout the US, intending to enrol up to 103 patients across as many as 15 sites.
The Acolyte System is designed to deliver real-time intravascular imaging during coronary CTO procedures.
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By GlobalDataIt aims to support controlled guidewire true-lumen crossing and targeted re-entry into the correct blood flow channel distal to the lesion, a technical challenge in interventional cardiology.
By integrating optical coherence tomography (OCT) directly into a crossing and re-entry catheter, Acolyte seeks to enhance procedural predictability, safety, and efficiency, allowing for concurrent fluoroscopy and OCT wire delivery.
The system has received breakthrough device designation from the US Food and Drug Administration (FDA) and acceptance into its Total Product Life Cycle Advisory Programme (TAP).
Elumn8 Medical CEO Joe Knight said: “We are excited to secure the initial close of our Series C financing and to introduce Elumn8 Medical as the next chapter in our company’s growth.
“This funding strengthens our ability to execute on our clinical and regulatory strategy. We are grateful to the investors who have demonstrated confidence in our vision for this important therapeutic option.”
